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The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs.
The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs. The Journey II BCS Knee System was designed to resect and replicate both the PCL and ACL, the Journey II CR System retains the posterior cruciate ligament, while the Journey II XR System retains the cruciate and collateral ligaments so they remain intact.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Journey II Bi-Cruciate Stabilized | Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected |
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| Journey II Cruciate Retaining | Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained) |
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| Journey II Bi-Cruciate Retaining | Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Journey II Bi-Cruciate Stabilized TKA | Device | Total Knee Arthroplasty System |
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| Measure | Description | Time Frame |
|---|---|---|
| Medial AP Translations, in mm | Anterior Posterior (AP) translations, in mm, of medial femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion. | At least 6 months postoperative |
| Lateral AP Translations, in mm | Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion. | At least 6 months postoperative |
| Maximum Flexion, in Degrees | Maximum weight-bearing flexion, in degrees, during Deep Knee Bend Activity. Maximum flexion indicated how far a participant can bend their knee during a DKB. A larger number indicates greater flexion, i.e. more bending. | At least 6 months postoperative |
| Axial Rotation, in Degrees | Axial Rotation, in degrees, during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their squat activity. A positive number indicates external femorotibial axial rotation from full extension to maximum flexion, and a negative number indicates internal femorotibial axial rotation from full extension to maximum flexion. | At least 6 months postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs
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| Name | Affiliation | Role |
|---|---|---|
| Michael LaCour, PhD | The University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Tennessee | Knoxville | Tennessee | 37996 | United States |
Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified.
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| ID | Title | Description |
|---|---|---|
| FG000 | Journey II Bi-Cruciate Stabilized | Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected Journey II Bi-Cruciate Stabilized TKA: Total Knee Arthroplasty System |
| FG001 | Journey II Cruciate Retaining |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2022 |
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| Journey II Cruciate Retaining TKA | Device | Total Knee Arthroplasty System |
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| Journey II Bi-Cruciate Retaining TKA | Device | Total Knee Arthroplasty System |
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Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained) Journey II Cruciate Retaining TKA: Total Knee Arthroplasty System |
| FG002 | Journey II Bi-Cruciate Retaining | Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained Journey II Bi-Cruciate Retaining TKA: Total Knee Arthroplasty System |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Journey II Bi-Cruciate Stabilized | Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected Journey II Bi-Cruciate Stabilized TKA: Total Knee Arthroplasty System |
| BG001 | Journey II Cruciate Retaining | Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained) Journey II Cruciate Retaining TKA: Total Knee Arthroplasty System |
| BG002 | Journey II Bi-Cruciate Retaining | Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained Journey II Bi-Cruciate Retaining TKA: Total Knee Arthroplasty System |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Medial AP Translations, in mm | Anterior Posterior (AP) translations, in mm, of medial femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion. | Posted | Mean | Standard Deviation | millimeters | At least 6 months postoperative |
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| Primary | Lateral AP Translations, in mm | Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their DKB activity. A positive number indicated anterior sliding from full extension to maximum flexion, and a negative number indicated posterior rollback from full extension to maximum flexion. | Posted | Mean | Standard Deviation | millimeters | At least 6 months postoperative |
| ||||||||||||||||||||||||||||||||||
| Primary | Maximum Flexion, in Degrees | Maximum weight-bearing flexion, in degrees, during Deep Knee Bend Activity. Maximum flexion indicated how far a participant can bend their knee during a DKB. A larger number indicates greater flexion, i.e. more bending. | Posted | Mean | Standard Deviation | degrees | At least 6 months postoperative |
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| Primary | Axial Rotation, in Degrees | Axial Rotation, in degrees, during Deep Knee Bend Activity. Values are based on the participants range of motion throughout their squat activity. A positive number indicates external femorotibial axial rotation from full extension to maximum flexion, and a negative number indicates internal femorotibial axial rotation from full extension to maximum flexion. | Posted | Mean | Standard Deviation | degrees | At least 6 months postoperative |
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adverse events would be noted on day of data collection. therefore the adverse events would be noted immediately, i.e. 1 day.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Journey II Bi-Cruciate Stabilized | Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL resected Journey II Bi-Cruciate Stabilized TKA: Total Knee Arthroplasty System | 0 | 25 | 0 | 25 | 0 | 25 |
| EG001 | Journey II Cruciate Retaining | Subjects who have received a Journey II Total Knee Arthroplasty with only the ACL resected (therefore PCL retained) Journey II Cruciate Retaining TKA: Total Knee Arthroplasty System | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Journey II Bi-Cruciate Retaining | Subjects who have received a Journey II Total Knee Arthroplasty with both the ACL and PCL retained Journey II Bi-Cruciate Retaining TKA: Total Knee Arthroplasty System | 0 | 10 | 0 | 10 | 0 | 10 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael LaCour | University of Tennessee | 865-974-9376 | mlacour@utk.edu |
| May 16, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 18-85 |
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| 85+ |
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